MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. CERVALIGN ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	725-090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on (b)(6) 2026.It was reported that the tip of a rigid screw inserter broke while tightening a screw during an anterior cervical discectomy and fusion procedure.An alternative instrument was utilized to successfully complete the procedure and there was no delay or known patient complications associated with this malfunction.The broken tip was successfully recovered from the screw head and disposed of at the hospital facility.A return authorization was issued for the return of the complaint instrument, which was received by the manufacturer for assessment on (b)(6) 2026.
Additional Manufacturer Narrative
A visual assessment of the returned rigid screw inserter showed an instrument with repeated use as identified by worn laser markings and surface scratches.Of note, the sleeve of the instrument was not returned.The complainant confirmed the sleeve was not engaged with the inserter at the time of the malfunction and was not relevant to the complaint.The distal tip of the rigid screw inserter was fractured and missing as reported.A functionality assessment was not performed due to the damaged condition of the return driver, which was removed from distributable inventory.A dhr review was performed for lot #5570 and no manufacturing anomalies were identified.The lot met specifications prior to being released to distributable inventory on (b)(6) 2024.A rework for one instrument of this lot was performed and released to distributable inventory on (b)(6) 2024.It was reported that the surgeon inserted a self-drilling variable angle screw into hard patient bone.The root cause of this complaint could not be reliably determined; however, it may be possible that the increased resistance of the screw drilling into the hard bone would cause increased pressure on the screw inserter's interface, which may result in the observed tip malfunction.There has been one other complaint of a similar nature in the past 12 months.The manufacturer will continue to monitor for reports of damaged rigid screw inserters and will facilitate and perform complaint investigations as appropriate.

• Brand Name: CERVALIGN ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 24916670
• Report Number: 3005031160-2026-00014
• Device Sequence Number: 10495197
• Product Code: KWQ
• UDI-Device Identifier: 00840311211135
• UDI-Public: 00840311211135
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K211408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 725-090
• Device Lot Number: 5570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown